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Not yet recruitingNAINTERVENTIONAL

A Comparative Study of Erector Spinae Fascia (ESF) Injection and Dry Needling Combined With Functional Rehabilitation (FR) in Patients With Chronic Low Back Pain Who Have Undergone Spinal Surgery (SPIN-NEED)

This research trial, called SPIN-NEED, is for people in the UK who have long-lasting lower back pain even after having spinal surgery. Many people experience chronic back pain, and it can really affect their daily lives. While exercises are a common treatment, this study wants to see if adding an ultrasound-guided injection near the spine (called an Erector Spinae Fascia injection) or a technique called dry needling can provide more pain relief. The main goal is to help people feel less pain, which in turn could make it easier for them to do their exercises and get back to their normal activities. The study also includes comparing these treatments to a neutral 'placebo' treatment to understand their true effects.

At a glance

Status
Not yet recruiting
Phase
NA
Sponsor
Clinique de la Côte d'Emeraude
Enrolment target
120
Start
01 May 2026
Estimated completion
31 Mar 2029

What is this study about?

Many people in the UK suffer from ongoing lower back pain, and sometimes, even after surgery, the pain can stick around. This can make it really hard to go about your daily life. This study, called SPIN-NEED, is designed to look into new ways to help people who are in this situation.

We know that exercise and rehabilitation are very important for managing back pain. However, this study is exploring if some additional treatments could help people get even more relief. Researchers want to compare two specific approaches: one is an injection near the spine, guided by ultrasound, which targets a muscle layer called the erector spinae fascia. The other is a technique called dry needling, where fine needles are inserted into specific muscle areas. Both of these will be given alongside a regular exercise programme. The study also includes a 'placebo' group, where people would receive an inactive treatment, often used in studies to see if the main treatments have a benefit beyond what might happen naturally or from the expectation of treatment.

The main aim of this study is to find out if these injections or dry needling can help reduce pain more effectively, making it easier for people to do their rehabilitation exercises. Ultimately, the hope is that this will improve people's overall well-being and their ability to do the things they enjoy. By comparing these methods, researchers hope to discover better ways to manage chronic lower back pain for people who have already had back surgery.

Key takeaways

  • This study is for adults with ongoing lower back pain after spinal surgery.
  • It compares an injection, dry needling, and a placebo, all combined with exercises.
  • The main goal is to find better ways to reduce pain and improve daily life.
  • All participants will receive a rehabilitation exercise program.
  • You can withdraw from the study at any time.

Who may be eligible?

This study is looking for adults who are at least 18 years old and are experiencing long-term lower back pain. To be considered, you must have had spinal surgery in the past for your back pain.

However, there are certain situations where you wouldn't be able to join the study. For example, if your back pain is due to a specific illness or injury (not just general chronic back pain), or if you already have a spinal cord stimulator fitted, you wouldn't be eligible. Also, if you have a medical condition that means you can't have corticosteroid injections, or if you are pregnant or breastfeeding, you wouldn't be able to take part. Researchers also cannot include people who have a very short life expectancy or those with memory or thinking difficulties that might make it hard to follow the study instructions.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Do you have chronic (long-lasting) lower back pain?
  3. Have you had spinal surgery for your back pain in the past?
  4. Are you not pregnant or breastfeeding?
  5. Do you not have a condition that prevents you from having steroid injections?
Answer every question to see your result.

What does participation involve?

If you join this study, you would be randomly assigned to one of three groups: either you would receive the erector spinae fascia injection, dry needling, or a placebo treatment. All groups would also take part in a functional rehabilitation exercise programme. The study will involve a series of visits for your treatments and assessments. These assessments will involve checking your pain levels and how well you can move and do daily activities. The researchers will also be monitoring you during and after the treatments. The total duration of your participation in the study would be determined by the specific follow-up schedule designed for this research.

Potential risks and benefits

Participating in this study might offer you the potential benefit of reduced back pain and improved movement, making it easier to engage in your rehabilitation exercises. However, as with any medical procedure, there are potential risks, such as discomfort or bruising from injections or dry needling, or allergic reactions to medication. The placebo group might not experience the same direct benefits as the active treatment groups. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

  • Emerald Coast Clinic
    Verified postcode
    St-Malo, France

Common questions

What is chronic lower back pain?

Chronic lower back pain is a pain in your lower back that has lasted for a long time, usually more than 3 months.

What is an Erector Spinae Fascia injection?

It's an injection, guided by ultrasound, given near the muscles in your lower back to help with pain.

What is dry needling?

Dry needling involves placing very fine needles into muscle trigger points to help ease pain and muscle tightness.

What is a placebo?

A placebo is a 'dummy' treatment that looks like the real treatment but has no active ingredients. It helps researchers understand if the real treatment has a specific effect.

Will I still get my usual rehabilitation exercises if I join?

Yes, all people taking part in this study will receive functional rehabilitation exercises along with their assigned treatment.

How to find out more

Marion Mandon, PhD

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Comparative Study of Erector Spinae Fascia (ESF) Injection…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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